Medical Device Regulatory Affairs Strategist
On-siteDubai, Dubai, United Arab Emirates
Job Summary
Regulatory affairs strategist for the medical-device domain focusing on the Middle East and Africa. Collaborates with product engineering to assess functionality and craft regulatory strategy; leads health-authority submissions (SFDA, MOHAP, MOPH, NHRA, SAHPRA, NAFDAC, EDA, PPB); maintains regulatory documentation, post-market surveillance, and surveillance activities; supports internal/external audits; serves as SME interpreting standards and QMS usage; manages regulatory and compliance projects; reviews labeling, marketing materials, clinical protocols, and design processes to ensure ongoing compliance; maintains global regulatory compliance across markets; builds relationships with regulatory agencies, affiliates, and cross-functional stakeholders for aligned regulatory outcomes.
Required Qualifications
- Bachelor’s degree in pharmacy, Biology, Biomedical Engineering, Engineering, Life Sciences, Health Sciences, or a related field.
- Experience with SaMD in Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent.
- Experience authoring submissions across assigned Middle East and Africa market.
- Comprehensive knowledge of regulatory requirements and processes across Middle East and Africa countries.
- Experience with sustaining and new product development is ideal.
- Strong problem-solving, planning, and organizational skills.
- Experience in working within a quality management system, preferably ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001.
- Excellent written and verbal communication skills.
- Experience engaging with regional trade associations, industry groups, or regulatory forums.
- Ability to adjust and adapt to changing priorities in a dynamic environment.
- Ability to perform in a fast-paced and continually evolving business environment.
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